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临床试验/NCT01413438
NCT01413438撤回2 期

Prospective, Randomized Controlled Trial of Surgical Resection Prior to Bevacizumab Therapy for Recurrent Glioblastoma Multiforme

National Institute of Neurological Disorders and Stroke (NINDS)0 个研究点开始时间: 2011年7月15日最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
主要终点
Median Overall Survival

研究概览

简要总结

Background:

  • Glioblastoma (GBM) is the most common malignant brain tumor in adults. Patients with GBM are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most GBMs start growing again. Bevacizumab, a chemotherapy drug, has shown promise in slowing the growth of GBMs. More research is needed to find out whether having surgery before starting bevacizumab is more effective than bevacizumab alone.

Objectives:

  • To compare surgery plus bevacizumab to bevacizumab alone in adults with glioblastoma.

Eligibility:

  • Individuals at least 18 years old whose glioblastoma has come back after treatment.

Design:

  • All participants will be screened with a physical exam, medical history, blood tests, and imaging studies.
  • Participants will be divided into two groups. One group will have surgery followed by bevacizumab. The other group will have the drug without surgery.
  • The first group will have surgery as soon as possible and will begin bevacizumab 4 weeks after surgery. The second group will start the drug as soon as possible.
  • Both groups will receive the drug as an infusion every 2 weeks. They will be monitored with frequent blood tests and imaging studies. The infusions will continue for as long as the drug is effective at preventing tumor regrowth.
  • Participants will be contacted every 4 weeks after they stop taking bevacizumab. They will answer followup questions either in person or by telephone.

详细描述

Objective

The objective of this prospective randomized controlled study is to determine the overall survival benefit of tumor resection in patients with recurrent glioblastoma multiforme (GBM).

Study Population

This study will recruit 42 adults with a diagnosis of recurrent grade 4 astrocytoma into each of two arms, for a total of 84 patients. All participants will be good candidates for elective surgical resection of their tumors according to the previously established NIH Recurrent Glioma Scale (NRGS), which uses performance status, tumor volume, and tumor involvement of critical/eloquent brain areas as prognostic criteria. Patients who require biopsy only or have previously been treated with bevacizumab will be excluded.

Design

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Median Overall Survival

时间窗: 2 years

次要结局

  • Progression-free survival (PFS) at 6 months & median PFS in each arm, objective response rate by the RANO criteria (OR), and overall survival rate at 6 and 12 months in each arm, compare rate of change in health-related quality of life.(2 years)

研究者

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